FDA Enforcement
Class II
Terminated
GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.
Recall: Z-0510-2020
·
Reported November 27, 2019
Enforcement
- Recall Number
- Z-0510-2020
- Event ID
- 83909
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Applied Medical Resources Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 27, 2019
- Initiation Date
- December 12, 2018
- Classification Date
- November 21, 2019
- Termination Date
- January 22, 2021
- Address
- 22872 Avenida Empresa, N/A, Rancho Santa Margarita, CA, 92688-2650, United States
Description
GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.
Reason
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Code Info
Model Number: TA211 Lot Numbers: 1342169 and 1340118
Distribution
Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.
Quantity
39 units Domestically and 112 units Internationally